FDA recall D-0385-2015

Akorn, Inc. · Class II · drug

Product

Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .

Reason for recall

Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-01-28
Report date: 2015-02-18
Termination date: 2017-11-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2015